EnteroMedics Inc. (NASDAQ: ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7269351-enteromedics-fda-approval-vbloc-maestro-system-weight-loss-device/
1 in 3 women will notice hair thinning in her lifetime, and it can start as early as her 20’s. Today, the hair regrowth category leader, ROGAINE® Brand, announced the official launch to market of Women's ROGAINE® 5% Minoxidil Topical Aerosol, the first and only FDA-approved, once-daily use treatment for Female Pattern Hair Loss containing 5 percent minoxidil in an elegant foam formula. Minoxidil is the only topical ingredient FDA-approved to help regrow hair.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7368851-introducing-women-s-rogaine-5-percent-minoxidil-topical-aerosol-fda-approved/
Hologic, Inc. (NASDAQ: HOLX) is kicking off Breast Cancer Awareness Month with the announcement that the Company's groundbreaking 3D mammography exam, available on the Selenia Dimensions platform, will be introduced to consumers today as Genius 3D Mammography. Hologic’s Genius 3D Mammography is the only 3D exam approved by the FDA as clinically superior to traditional mammography.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7254155-hologic-new-consumer-awareness-campaign-mammography-technology/
ACCU-CHEK Aviva Expert offers people with diabetes a new and easy way to simplify complex calculations to deliver precise insulin dosing advice.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the ACCU-CHEK® Aviva Expert system, the first and only blood glucose meter system with a built-in insulin calculator to be approved by the U.S. Food and Drug Administration (FDA), is now available by prescription. The device represents a significant advancement in blood glucose meter technology for people with diabetes who take multiple daily insulin injections. The meter’s integrated bolus calculator provides easy-to-use and reliable dose recommendations based on automated calculations, eliminating the need for manual dosing calculations and estimations.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7322751-roche-accu-chek-aviva-expert-blood-glucose-meter-now-available/
To help kids make healthful dietary choices, the U.S. Food and Drug Administration encourages kids to Read the Label!
The Nutrition Facts Label is a simple tool available on food and beverage packages. It lets kids know exactly what they’re eating and helps them choose and compare snacks and other foods. The earlier they start using the Nutrition Facts Label, the sooner they’ll be making choices that keep them feeling great and promote long-term good health!
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7106353-fda-national-childhood-obesity-month/
Exact Sciences Corp. (NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy–to–use screening test they can do in the privacy of their own home.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7092251-fda-approve-s-exact-sciences-cologuard-screening-test-colorectal-cancer/
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the ClearSight system.
The ClearSight system is a noninvasive monitor that provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7256451-edwards-fda-clearance-for-noninvasive-hemodynamic-monitoring-system/
FDA’s Read the Label Youth Outreach Campaign is an exciting initiative that challenges kids (ages 9 to 13) to “get their food facts first” by using the Nutrition Facts Label to make healthy food choices. Read the Label campaign materials enable parents and caregivers to help kids use this important tool.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7106352-fda-read-the-label-youth-outreach-campaign-tweens-healthy-choices
Inspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Inspire Upper Airway Stimulation (UAS) therapy for use in a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) who are unable to use Continuous Positive Airway Pressure (CPAP). Inspire therapy is a fully implanted neurostimulation device, the first of its kind for sleep apnea, that provides an alternative treatment that is proven, convenient and easy to use.
To view the Multimedia News Release, go to: http://www.multivu.com/mnr/7169651-fda-approves-inspire-upper-airway-stimulation-therapy-sleep-apnea
Eisai Inc. today announced the launch of a new national television advertising campaign for BELVIQ® (lorcaserin HCl) CIV, an FDA-approved prescription therapy for chronic weight management. The advertisement will air on numerous channels including Lifetime, Oxygen and AMC.
The spot illustrates the struggles many people face when they are trying to lose or control their weight. BELVIQ is presented as a targeted approach to weight loss, that, when combined with diet and increased activity, may help some patients lose weight and keep it off.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7161051-eisai-launches-national-television-campaign-belviq-lorcaserin-hcl-civ
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval and launch of the Cochlear™ Nucleus® Hybrid Implant System, a revolutionary new hybrid hearing solution that helps people who may hear a little but are still missing a lot, even with their hearing aids. The Nucleus Hybrid System is a unique combination of proven solutions, which allows people to get back what they've been missing by amplifying the low-pitched hearing a person does have while restoring access to the high-pitched hearing they've lost. People who are candidates for the technology no longer have to worry about straining to hear with their hearing aids as the Nucleus Hybrid System will allow them to maximize their hearing in all frequencies.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7150651-cochlear-fda-approval-u-s-launch-cochlear-nucleus-hybrid-implant-system
February is American Heart Month, and consumers should be aware that a high-sodium diet can increase their risk of developing high blood pressure. An estimated one in three Americans suffer from high blood pressure, which can increase the risk of developing cardiovascular disease – the leading cause of death in men and women in the United States.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/65492-u-s-fda-reduce-sodium-intake-by-using-the-nutrition-facts-label
